Oral sildenafil citrate lacks genotoxicity and cytotoxicity in a primate model: Callithrix jacchus

Lemus-Varela, M L; Sola, Augusto; Gómez‐Meda, Belinda Claudia; Zamora‐Pérez, Ana Lourdes; Ramos-Ibarra, María Luisa; Batista-González, Cecilia M.; Zúñiga‐González, Guillermo Moisés

doi:10.1038/sj.jp.7211518

Cited by 8 publications

(7 citation statements)

References 34 publications

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“…Sildenafil citrate was previously tested by Snyder and Green (2001) and Lemus‐Varela et al (2006), but was detected neither mutagenic, nor carcinogenic.…”

Section: Discussionmentioning

confidence: 99%

Genotoxic effects in fish induced by pharmacological agents present in the sewage of some Italian water‐treatment plants

Rocco¹,

Frenzilli²,

Zito³

et al. 2011

Environmental Toxicology

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The presence of pharmaceutical substances in the municipal effluents is currently considered the principal source of bio-active molecule emissions into aquatic environments. This study analyzes the genotoxic damage caused by gemfibrozil and atorvastatin, two regulators of the hematic level of lipids, and sildenafil citrate, a vasodilator, on the teleost Danio rerio. The genotoxicity of these three compounds was evaluated using the comet assay, diffusion assay, and RAPD-PCR. The alkaline version (pH 12.1) of the comet assay was used for the erythrocytes of the zebrafish to evaluate the presence of single strand DNA breaks. Furthermore, the diffusion assay was used to estimate the number of apoptotic cells. The fish were treated with the three pharmacological agents at the average concentrations previously found at some Italian treatment plants and were then sacrificed from 5 to 35 days after exposure. The data of the comet assay showed a statistically significant loss of DNA integrity after 5 days of exposure to atorvastatin and after one week of exposure to gemfibrozil. This damage was, however, repaired after 14 days. Sildenafil citrate produced, instead, a statistically significant loss of DNA integrity at the concentrations found only after 35 days of exposure. The genotoxicity at the molecular level was tested by RAPD-PCR. The results from this investigation are in agreement with those from two other tests, confirming the efficacy of the use of the three experimental approaches for the complete evaluation of genotoxic damage.

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“…Sildenafil citrate was previously tested by Snyder and Green (2001) and Lemus‐Varela et al (2006), but was detected neither mutagenic, nor carcinogenic.…”

Section: Discussionmentioning

confidence: 99%

Genotoxic effects in fish induced by pharmacological agents present in the sewage of some Italian water‐treatment plants

Rocco¹,

Frenzilli²,

Zito³

et al. 2011

Environmental Toxicology

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“…It seems that these effects are dose-dependent. There is experimental evidence that there are no genetic defects 26 and no neurodevelopmental impairment associated with its use. 6 In this study, as well as in the previous studies mentioned, 19,20 no systemic hypotension was observed.…”

Section: Discussionmentioning

confidence: 99%

The Use of Sildenafil in Persistent Pulmonary Hypertension of the Newborn

Vargas-Origel¹,

Gómez-Rodríguez²,

Aldana-Valenzuela³

et al. 2009

Amer J Perinatol

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We evaluated the effectiveness of sildenafil in the treatment of neonatal pulmonary hypertension. We performed a double-blind randomized clinical trial in 51 full-term infants with persistent pulmonary hypertension confirmed by Doppler echocardiography. Patients were divided in two groups: 20 infants in group A received placebo when the oxygenation index was >20, and 31 infants in group B received 3 mg/kg of oral sildenafil every 6 hours. Arterial blood gases were taken at 1, 4, 7, 13, 19, and 25 hours after treatment was started. Main outcome measures were oxygenation changes, time on mechanical ventilation, and mortality. Both groups were comparable in general variables as well as in illness severity. We observed better oxygenation parameters after 7 hours of sildenafil treatment, but no significant changes were found in the placebo group. Mortality was higher in the placebo group (40%) than in those infants who received sildenafil (6%; P = 0.004), although no difference was found in time on mechanical ventilation between groups. Our results confirm that sildenafil may be a useful adjuvant therapy for term infants with pulmonary hypertension in centers lacking inhaled nitric oxide and extracorporeal membrane oxygenation.

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“…También se ha comunicado la vasodilatación de la venas retinianas mayores 54 . En relación a la genotoxicidad y la citotoxicidad del sildenafilo, Lemus et al 55 recientemente han publicado un estudio que tranqui-Sola A y Baquero H. Sildenafilo oral en medicina neonatal liza, al demostrar en un modelo de primate, que este fármaco no produce este tipo de toxicidad.…”

Section: Efectos Adversosunclassified

Sildenafilo oral en medicina neonatal “Investigado para adultos, usado también por neonatos”

Sola

Baquero

2007

Anales de Pediatría

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Oral sildenafil citrate lacks genotoxicity and cytotoxicity in a primate model: Callithrix jacchus

Cited by 8 publications

References 34 publications

Genotoxic effects in fish induced by pharmacological agents present in the sewage of some Italian water‐treatment plants

Genotoxic effects in fish induced by pharmacological agents present in the sewage of some Italian water‐treatment plants

The Use of Sildenafil in Persistent Pulmonary Hypertension of the Newborn

Sildenafilo oral en medicina neonatal “Investigado para adultos, usado también por neonatos”

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